[Remote] Country Approval Specialist - FSP- Poland at Thermo Fisher Scientific

Poland

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Skills

Key technologies and capabilities for this role

Regulatory SubmissionsAttention to DetailAccuracyClinical TrialsMoH SubmissionsEC SubmissionsImport License Applications

Questions & Answers

Common questions about this position

What is the work arrangement or location policy for this role?

This is a full-time position with a standard Monday-Friday work schedule in an office environment.

What are the key responsibilities of the Country Approval Specialist?

The role involves preparing, reviewing, and coordinating local regulatory submissions, providing local regulatory strategy advice, coordinating site start-up activities, and ensuring alignment with timelines for site activation.

What skills or qualities are essential for this position?

A strong attention to detail is required, along with the ability to take ownership of document accuracy and hold yourself and others accountable.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes meaningful work that positively impacts global health, provides resources for career goals, and fosters collaboration in clinical operations to deliver high-quality, cost-efficient studies.

What makes a strong candidate for this Country Approval Specialist role?

Candidates with experience in regulatory submissions, strong attention to detail, and the ability to coordinate with internal teams and achieve target cycle times for site activation will stand out.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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